Physical Activity and Balance Changes in Operated Patient... | NCT05566509

Studies
Physical Activity and Balance Changes in Operated Patients Because of Breast Cancer

NCT05566509

Sponsor

Saglik Bilimleri Universitesi

Status

Completed

Last Update Posted

Oct 4, 2022Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Balance and Physical Activity Deficits After Breast Surgery

Interventions

Breast excision

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008Actual

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2016Actual

First Submitted Date

Sep 30, 2022

First Submission Date that Met QC Criteria

Sep 30, 2022

First Posted Date

Oct 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2022

Last Update Posted Date

Oct 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer. A significant decrease in the physical activity occurred, Their balance did not deteriorate in the follow-ups. This was independent of the type of the surgery performed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breast Conservative Surgery		The patients who had minimally invasive surgery.	Procedure: Breast excision
Mastectomy		The patients who had invasive and destructive surgery.	Procedure: Breast excision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breast excision	Procedure	some patient had minimal excision, some had maximal excision.	Breast Conservative Surgery Mastectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
decrease in the physical activity	Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer.	2

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who had breast cancer surgery

Exclusion Criteria:

balance disorders, physical disability that will affect balance (polio sequelae) and neurological diseases with balance system and/or peripheral nervous system involvement (diabetic neuropathy and familial/genetic neuropathies, Parkinson's Disease, Multiple Sclerosis, Alzheimer's Disease), bone metastasis, patients who have undergone reconstructive surgery

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

woman breast cancer

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

breast cancer

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided